Unilateral Bevacizumab for Bilateral Diabetic Macular Edema

NCT00496405 | Withdrawn Phase 4

• 1 other identifier: APEC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The endothelial growth factor (VEGF), has been implied in the genesis of diverse Neovascular disease. In the industrialized and developing countries, the main cause of blindness is the diabetic retinopathy. Bevacizumab (Avastin, genentech, Inc., San Francisco, California, the USA) is a drug.In the last years its use "off-label", in ophthalmology field, has become popular. This is due to its proven safeness and effectiveness for the treatment of diverse ocular diseases. A lot has been speculated about the systemic absorption of Bevacizumab. It is for that reason that the objective of this study is the systematic and random revision of the fellows eyes, of the patients programmed for the intravitreal administration of Bevacizumab, with bilateral macular edema. In such a way that the therapeutic value in the fellow eye of bevacizumab can be determined

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Keywords

Vascular endothelial growth factor.; Retinal Thickness; Diabetic Macular Edema; Optical Coherent Tomography

Outcome Measures

Primary Outcomes (1)

• Retinal thickness

  Interventional

Secondary Outcomes (1)

• Best corrected visual acuity

Interventions

bevacizumab DRUG

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient greater of 30 years old, with bilateral diffuse diabetic macular edema, with any degree of diabetic retinopathy that has been programmed for Bevacizumab intravitreal administration in one of both eyes.
• Bilateral macular Thickening, measured by OCT of 225mm or bigger.
• Pupil dilatation greater than 5mm.
• Patient with no previous treatment for diabetic macular edema.

You may not qualify if:

• Focal diabetic macular edema or macular edema of different etiology, besides diabetes. (uveitis, pseudophakic patients, vitreous-retinal traction, CRVO, BRVO, CSC).
• Macular edema 3B patter, measured by OCT, according to the macular edema classification.
• Medical history of severe thromboembolic events, uncontrolled arterial hypertension, transitory ischemic attacks, cardiac stroke, acute cerebral vascular event.
• Pregnant women or breast feeding women
• Know allergy to Bevacizumab

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociación para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

Related Publications (1)

• Velez-Montoya R, Fromow-Guerra J, Burgos O, Landers MB 3rd, Morales-Caton V, Quiroz-Mercado H. The effect of unilateral intravitreal bevacizumab (avastin), in the treatment of diffuse bilateral diabetic macular edema: a pilot study. Retina. 2009 Jan;29(1):20-6. doi: 10.1097/IAE.0b013e318186c64e.

  PMID: 18784623 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Raul Velez-Montoya, MD

  Asociación para Evitar la Ceguera en Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: April 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

ME (1)